Anticoagulant Medication Research Articles

A surgical case of anti-coagulant ileus mimicking small-bowel tumors: a case report

BackgroundAnti-coagulant ileus, characterized by intramural hematoma due to excessive anti-coagulant therapy, presents a diagnostic challenge. Although previously considered uncommon, recently, reporting cases of anti-coagulant ileus have become more frequent. Herein, we report a rare surgical case of anti-coagulant ileus mimicking small-bowel tumors.Case presentationA 79-year-old man was admitted to our hospital for fatigue. He had been administered warfarin for 5 months for atrial fibrillation. On admission, the patient exhibited mild epigastric tenderness. Laboratory test results revealed anemia (hemoglobin, 8.4 g/dL); unmeasurably prolonged prothrombin time (PT) with international normalized ratio (INR) > 8; and elevated soluble interleukin 2 receptor (sIL-2R) levels (849 IU/mL; normal range, 122–496 IU/mL). Abdominal plain computed tomography (CT) showed a circumferentially thickened intestinal wall at one site in the jejunum and two in the ileum. After hospitalization, bowel obstruction did not improve with conservative treatment. Suspecting small-bowel tumors such as lymphoma, the patient subsequently underwent open surgery on day 3 after admission. No obvious tumor mass was observed intra-operatively. However, only thickened and hemorrhagic segments were identified at the suspected sites. We performed partial jejunal and ileal resections of 12 and 27 cm, respectively. Histopathology confirmed submucosal congestion, edema, and hemorrhage in each area without tumor components, leading to the final diagnosis of intramural hematoma. The postoperative course was uneventful, and he was discharged on postoperative day 9. No recurrence occurred during the 5-year follow-up period.ConclusionsWe encountered a surgical case of anti-coagulant ileus, which was difficult to differentiate from malignant lymphoma based on CT findings and high sIL-2R levels. The possibility of anti-coagulant ileus should always be considered in patients on long-term anticoagulation medication and bowel obstruction with high PT-INR values.

Therapeutic changes of systemic lupus erythematosus (SLE) patients in pregnancy and feto-maternal outcomes: a retrospective cohort study.

Patients with systemic lupus erythematosus (SLE) frequently show non-compliance with their medication. We evaluated the compliance of patients with SLE in Jordan with their medication and the relationships with fetal and maternal outcomes. We performed a retrospective cohort study of patients with SLE who had no co-morbidities or antiphospholipid syndrome; and were taking only prednisolone, hydroxychloroquine, and/or antiplatelet and anticoagulant medication. We studied 173 pregnancies. Prednisolone was administered around pregnancy in 50 (28.9%) of these. The compliance with hydroxychloroquine, prednisolone, and anticoagulant and antiplatelet medication was 87.5%, 91.4%, and 97.3%, respectively. Non-compliance with anticoagulant/antiplatelet therapy was significantly associated with pregnancy-related complications. No complications developed in participants who were non-compliant with prednisolone therapy. The mean pre-pregnancy Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) for the pregnancies was 3.7, indicating low disease activity. Pregnancies with high pre-pregnancy SLEDAI scores tended to be more likely to have preterm deliveries, intrauterine growth restriction, and stillbirth. Postpartum relapse tended to be associated with higher pre-pregnancy SLEDAI. In patients with pre-conceptional low SLE activity, changes in therapeutic compliance during pregnancy are not associated with adverse outcomes. In addition, post-partum relapse is not associated with pre-pregnancy SLEDAI score in therapeutically compliant patients.

Safety and Outcomes of Outpatient Pleural Drainage in Symptomatic Postoperative Cardiac Surgery Patients.

Symptomatic pleural effusions and anticoagulant/antiplatelet medication use in postoperative cardiac surgery are common. Guidelines and recommendations are currently mixed regarding medication management related to invasive procedure performance. We aimed to describe the outcomes of postoperative cardiac surgery patients referred for outpatient, symptomatic pleural effusion management. A retrospective study of post-cardiac surgery patients undergoing outpatient thoracentesis from 2016 to 2021 was performed. Demographics, operative details, pleural disease characteristics, outcomes, and complications were collected. Odds ratios with confidence intervals were estimated and adjusted by multivariate logistic regression to investigate the association with multiple thoracenteses. A total of 110 patients underwent 332 thoracenteses. The median age was 68 years and most common operation was coronary artery bypass. Anticoagulation or antiplatelet use was identified in 97%. Thirteen complications were identified, with all major complications (n=3) related to bleeding. The amount of fluid present at the time of initial thoracentesis (>1500 milliliters) was associated with increased odds ratio of subsequent multiple thoracentesis (Unadjusted odds ratio, 6.75 (CI - 1.43 to 31.9). No other variables had a significant association with the need for multiple procedures. Within a postoperative cardiac surgery population presenting with symptomatic pleural disease, we observed that thoracentesis performed on antiplatelet and/or anticoagulant medication is relatively safe. We also identified that many patients can be managed as outpatients and that most pleural effusions remain self-limited. The presence of larger amounts of pleural fluid at initial thoracentesis may be associated with increased odds for additional drainage.

An Overview of Clinical Trials on the Duration of Dual Antiplatelet Therapy and the Scope of Novel Oral Anticoagulants Following Percutaneous Coronary Intervention

ABSTRACT After percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) is an important therapy for preventing thrombotic events. Numerous clinical trials have been conducted to determine the ideal length of therapy in relation to the duration of DAPT. Similar to this, various clinical trials have investigated the use of novel oral anticoagulant (NOAC) medication in conjunction with DAPT following PCI. In this review, we sum up the findings from various significant clinical studies that have influenced the duration of DAPT and the scope of NOAC therapy following PCI.

Challenging anticoagulation decisions in atrial fibrillation: a narrative review.

Atrial fibrillation (AF) is common and warrants consideration of oral anticoagulant (OAC) medication. Usually, the decision is straightforward, following the pathway outlined in the European Society of Cardiology's guideline; however, certain situations fall outside of this evidence base - such as a diagnosis of subclinical AF made via implanted devices or wearable electrocardiogram monitors, or alternatively diagnosis of 'secondary AF' following a major stressor. Subclinical AF is associated with stroke, though not to the extent of clinical AF, and the benefits of anticoagulation appear to be lower. Longer episodes are more clinically meaningful, and recent randomised controlled trials have demonstrated that some patients derive benefit from OAC. Similarly, when AF is triggered by sepsis or non-cardiac surgery, specific evidence supporting OAC initiation is lacking and clinician behaviour is variable. Observational data demonstrate poorer outcomes in these patients, implying that the perception of a transient, reversible phenomenon may not be correct. Contrastingly, cardiac surgery very frequently induces AF, and the benefits of anticoagulation rarely outweigh the risks of bleeding. Following ischaemic stroke, recent evidence suggests that early (re-)initiation of OAC should be considered as this does not increase the risk of haemorrhagic transformation as previously hypothesised. This narrative review summarises the available literature and outlines, where possible, practical advice for clinicians facing these common clinical dilemmas.

Culprits of Medication-Induced Telogen Effluvium, Part 2.

Telogen effluvium (TE) is a common mechanism underlying medication-related alopecia. The inciting cause of TE may be difficult to identify due to delays in clinically apparent hair loss. Because medication-induced TE is a nonscarring alopecia that typically is reversible, appropriate management requires identification of the underlying trigger and cessation of potential culprit medications. In part 2 of this 2-part series on medication-induced TE, we focus on anticoagulant and antihypertensive medications.

Anticoagulation Stewardship to Bridge the Implementation Gap in Perioperative Anticoagulation Management.

Lack of alignment of care protocols among providers in health care is a driver of increased costs and suboptimal patient outcomes. Perioperative anticoagulation management is a good example of a complex area where protocol creation is a clinical challenge that demands input from multiple experts. Questions regarding the need for anticoagulation interruptions are frequent. Yet, due to layers of complexity involving analysis of anticoagulation indication, surgical risk, and anesthesia-associated bleeding risk as well as institutional practices, there is heterogeneity in how these interruptions are approached. The recent perioperative anticoagulation guidelines from the American College of Chest Physicians summarize extensive evidence for the management of anticoagulant and antiplatelet medications in patients who undergo elective interventions. However, implementation of these guidelines by individual clinicians is highly varied and often does not follow the best available clinical evidence. Against this background, anticoagulation stewardship units, which exist to improve safety and quality monitoring for the anticoagulated patient, are of growing interest. These units provide a bridge for the implementation of value-based, high-quality guidelines for patients who need perioperative anticoagulation interruption. We use a case to pragmatically illustrate the problem and tactics for change management and implementation science that may facilitate the adoption of perioperative anticoagulation guidelines.

Survey of Using Oral Anticoagulants in Patient with Non-valvular Atrial Fibrillation.

In Vietnam, there has been no survey conducted on the prescribing and monitoring practices of oral anticoagulants to ensure that patients with atrial fibrillation receive appropriate. Objective: Therefore, we conducted this research to clarify the aforementioned issue in our hospital. We carried out a cross-sectional study by reviewing outpatient electronic medical records at the University Medical Center in Ho Chi Minh City. Our study included 1087 patients aged 18 years or older diagnosed with non-valvular atrial fibrillation (NVAF), who visited the Cardiology clinic between January 1st, 2021, and June 30th, 2021. Among the 1087 patients with non-valvular atrial fibrillation (NVAF), 1036 were eligible for anticoagulant therapy. However, only 847 (81.8%) received prescriptions for either Vitamin K antagonists (VKAs) (n=129, 15.2%) or Non-Vitamin K antagonist oral anticoagulants (NOACs) (n=718, 84.8%). NOAC prescriptions were more commonly found in patients aged 75 or older (adjusted odds ratio [OR]=2), those with health insurance coverage (adjusted OR=2.9), and in individuals with a history of hypertension (adjusted OR=2). On the contrary, patients with a farming occupation were less likely to be prescribed NOACs (adjusted OR=0.4). About 75% of patients adhered to the guidelines recommending close monitoring during anticoagulant treatment. Notably, inappropriate prescriptions were identified in 27.7% of cases, especially among those with no recorded body weight (which is necessary for precise dosing based on creatinine clearance), those without health insurance, those with undocumented CHA2DS2-VASc scores, or those who were concurrently using antiplatelet agents. A discrepancy persists between clinical guidelines and the actual practice in diagnosing and managing patients with non-valvular atrial fibrillation (NVAF). It is crucial to prioritize the regular reevaluation of thromboembolic risk scores at follow-up appointments, ensure strict adherence to clinical monitoring standards, and align anticoagulant medication prescriptions with established guidelines.

Evaluation of Clotting Parameters in Pregnant Women with Placental Blood Clots: Impact of Patient Characteristics and Assessment of Clexane Efficacy

Background: Clexane is used in pregnant women (PW) to minimize placental blood clotting (PBC) and fetal danger. Standard coagulation tests such as prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) are critical for anticoagulant medication optimization. As a result, the study's goal was to evaluate the efficacy of clexane as well as adherence to the American Heart Association's recommended limits for routine coagulation tests. Methods: The study included forty normal PW as controls and forty PW with PBC as patients from Al-Mafraq Hospital in Jordan. Patients were administered daily subcutaneous injections of 40 mg of clexane as an anticoagulant, in conjunction with a daily 75 mg aspirin regimen. During the first trimester, 5 ml of venous blood were drawn from each participant. The PT, INR and APTT were measured. This assessment also considered variables including plasma fibrinogen concentration (PFC), age, body mass index (BMI), blood type, and fetal gender. Results: The mean age \(\pm\) SD were 29.6 \(\pm\) 6.2 for the patient group and 28.3 \(\pm\) 5.9 years for the control group. The changes in PT, INR, APTT and PFC between the control and patient groups were statistically significant independent of mother's age, BMI, baby gender, or blood type. Patients displayed inadequate anticoagulation with an INR of 0.8, falling below the recommended therapeutic range of 2-3 for anticoagulant treatment. Surprisingly, by the end of the clinical study, all patients under investigation had safely delivered their babies without difficulties. Conclusion: The observed rise in fibrinogen levels among patients may contribute to PBC formation, necessitating further investigation. Evaluation of the safety and efficacy of a combined 40 mg Clexane and 75 mg aspirin regimen in PW from the Al-Mafraq region, Jordan, is warranted.

The Neurosurgeon's Dilemma—Do Antiplatelet/Anticoagulant Medications Increase the Risk of Catheter-Associated Hemorrhage in External Ventricular Drain Placement?

IntroductionExternal ventricular drain (EVD) placement is a common neurosurgical procedure that can be performed at bedside. A frequent complication following EVD placement is catheter-associated hemorrhage (CAH). The hemorrhage itself is rarely clinically significant but may be complicated in patients taking anticoagulant or antiplatelet (AC/AP) medications. MethodsA total of 757 patients were who underwent EVD placement at bedside were included as part of a retrospective study at a large academic medical center. Demographic factors, use of AC/AP therapies, and several other clinical variables were recorded and assessed in univariate and multivariate regression analysis for association with CAH and mortality. ResultsOne hundred (13.2%) patients experienced CAH within 24 hours of the procedure. After univariate analysis, in two tandem-run multivariate regression analyses after stepwise variable selection, use of two or more AC/AP agents (OR=2.362, p=0.020) and dual antiplatelet therapy with aspirin and clopidogrel (OR=3.72, p=0.009) were significantly associated with CAH. Use of non-coated catheters was a protective factor against CAH compared to use of antibiotic-coated catheters (OR=0.55, p=0.019). Multivariate analysis showed age, multi-agent therapy, and thrombocytopenia were significantly associated with increased mortality. ConclusionThere was increased risk of CAH after EVD placement in patients taking more than one AC/AP agent regardless of presenting pathology. In particular, use of aspirin and clopidogrel combined was associated with significantly higher odds of CAH, although it was not associated with higher mortality. In addition, there appears to be an association between use of antibiotic-coated catheters and CAH across univariate and multivariate analysis.

Quality of anticoagulation control among patients receiving vitamin K antagonist in pharmacist-managed anticoagulation medication therapy adherence clinic

Quality of anticoagulation control among patients receiving vitamin K antagonist in pharmacist-managed anticoagulation medication therapy adherence clinic

Perioperative Optimization and Management of the Oral and Maxillofacial Surgical Patient: A Narrative Review on Updates in Anticoagulation, Hypertension and Diabetes Medications

PurposeThe preoperative management guidelines of surgical patients are constantly evolving as newer evidence-based research is published. Oral and maxillofacial surgeons need to be current with the increasingly more complex new drug therapies and updated national association(s) guidelines. This narrative review provides a synopsis with important reference tables for updated preoperative optimization guidelines for anticoagulation, antiplatelet therapy, antihypertensive management, and glycemic control in the preoperative period for the oral and maxillofacial surgery patient. It also includes the most current anesthesia guidelines on glucagon-like peptide (GLP-1) receptor agonists. MethodsThe search strategy utilized pubmed.gov to identify the most recent national society guidelines and review articles pertinent to perioperative anticoagulation, antiplatelet therapy, antihypertensive management, and glycemic control. ResultsThe search identified 75 articles from the American College of Surgeons, American Heart Association, American Society of Anesthesiologists, American College of Cardiologists, in addition to recent reviews discussing the standard of care for optimization of patients in the perioperative period. ConclusionMedical optimization prior to surgery is important for safe and efficient surgical practice and has been shown to improve overall mortality. This narrative review provides a summary of the current data with recommendations focusing on four key points.

Rationale and design of a randomized clinical trial evaluating the efficacy of mechanical neuroprotection in reducing the risk of silent brain infarcts associated with percutaneous left atrial appendage closure: study protocol for a LAAC-SBI trial

BackgroundLeft atrial appendage closure (LAAC) procedures prevent cardioembolic stroke in patients with atrial fibrillation who have contraindications to oral anticoagulant medications. However, these procedures carry certain risks of peri-procedural complications. One such complication is silent brain infarcts (SBI), which can lead to cognitive impairment and mood disturbances. The implementation of mechanical neuroprotection systems during LAAC procedures may reduce the risk of SBI and associated cognitive and mood disorders.MethodsThe LAAC-SBI trial is a prospective, multicenter, randomized, and double-blind interventional study. The study aims to enroll a total of 240 patients, with 120 patients allocated to each group. The study group will evaluate the use of the Sentinel CPS during LAAC, while the control group will undergo LAAC procedures without the Sentinel CPS. The primary endpoint of the study is the number of new SBIs or stroke foci detected by diffusion-weighted magnetic resonance imaging (DW MRI). Secondary endpoints include deterioration of cognitive function, development of dementia syndrome, and occurrence of depressive disorders. These endpoints will be assessed using questionnaire tools such as the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), Controlled Oral Word Association Test (COWAT), and Hospital Anxiety and Depression Scale (HADS). The observational period for patients in the study is 2 years.DiscussionIf the study demonstrates a favorable outcome with reduced incidence of SBI and improved cognitive and mood outcomes in patients receiving cerebral protection devices during LAAC, it will have significant implications for clinical management standards. This would support the use of neuroprotection devices not only for LAAC but also in procedures such as atrial fibrillation ablation or transcatheter mitral valve interventions, where the risk of embolic events and subsequent brain injury may also be present.Trial registrationClinicalTrials.gov NCT05369195. Registration on 11.05.2022.

Antiphospholipid Antibodies and Vascular Thrombosis in Patients with Severe Forms of COVID-19.

Antiphospholipid antibodies (aPLA) are a laboratory criterion for the classification of antiphospholipid syndrome (APS) and are known to cause clinical symptoms such as vascular thrombosis or obstetric complications. It is suggested that aPLA may be associated with thromboembolism in severe COVID-19 cases. Therefore, we aimed to combine clinical data with laboratory findings of aPLA at four time points (admission, worsening, discharge, and 3-month follow-up) in patients hospitalized with COVID-19 pneumonia. In 111 patients with COVID-19 pneumonia, current and past history of thrombosis and pregnancy complications were recorded. Nine types of aPLA were determined at four time points: anticardiolipin (aCL), anti-β2-glycoprotein I (anti- β2GPI), and antiphosphatidylserine/prothrombin (aPS/PT) of the IgM, IgG, or IgA isotypes. During hospitalization, seven patients died, three of them due to pulmonary artery thromboembolism (none were aPLA positive). Only one of the five who developed pulmonary artery thrombosis was aPLA positive. Out of 9/101 patients with a history of thrombosis, five had arterial thrombosis and none were aPLA positive at admission and follow-up; four had venous thrombosis, and one was aPLA positive at all time points (newly diagnosed APS). Of these 9/101 patients, 55.6% were transiently aPLA positive at discharge only, compared to 26.1% without a history of thrombosis (p = 0.041). Patients with severe forms of COVID-19 and positive aPLA should receive the same dose and anticoagulant medication regimen as those with negative aPLA because those antibodies are mostly transiently positive and not linked to thrombosis and fatal outcomes.

Management of venous thromboembolism as a complication after Total laparoscopic hysterectomy with bilateral salpingectomy: A case report

Total laparoscopic hysterectomy (TLH) is a common procedure in gynecology, often performed to treat various gynecologic conditions. This case report presents a patient who underwent TLH with bilateral salpingectomy and subsequently developed a pulmonary embolism (PE) postoperatively. The patient, a 49-year-old woman with a history of adenomyosis and abnormal uterine bleeding (AUB) associated with endometrial hyperplasia – AUB-M, developed difficulty breathing and chest pain two days after surgery. Diagnostic tests revealed acute PE affecting both main pulmonary arteries. The patient received prompt medical treatment in the intensive care unit (ICU), including anticoagulation therapy, diuretics, oxygen support, and antibiotics. Her condition gradually improved, and she was discharged on oral anticoagulation medication after five days. The case highlights the importance of considering venous thromboembolism (VTE) as a potential complication, even in low-risk patients, and the need for further research to identify additional risk factors and improve preoperative care to prevent such life-threatening complications.

Development and Validation of RP-HPLC Method for the Determination of Enoxaparin Sodium in Dry Injection Formulation.

Enoxaparin sodium is an anticoagulant medication that is used as a blood thinning agent. It is mostly used for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). It is also used in certain surgeries and during pregnancy. For the treatment of acute coronary syndrome (ACS) and heart attacks, it may be used. Enoxaparin sodium was validated by the RP-HPLC method. A simple RP-HPLC method was developed in a single HPLC run in a dry powder injection formulation. All injections of HPLC sample were 20 μL volume. The chromatographic separation was completed in the isocratic mode. The used column was USP-L8 (250 mm × 4.6 mm) of BDS type of 10 μm meters in the same mobile phase throughout the analysis by using methanol and ultrapure water with a ratio of 7:93, respectively. The flow rate was 1.0 mL/min. The mobile phase was filtered through 0.45 μm filter paper, and isocratic elution was performed. The refractive index (RI) detector was used to analyze this sample. The specific peak of enoxaparin sodium was observed at 5:56 min. The calculated detection limit (LOD) was 0.351 ppm, and the calculated quantitation limit was 1.063 ppm. In repeatability of precision, the average calculated assay (%) was 100.85%, and the calculated RSD (%) was 0.01. In the accuracy test, the RSD (%) was 0.50, and the mean recovery (%) was 100.35. The system's suitability was within the limit. This newly developed method is proposed according to ICH guidelines, and rules and can be applied effectively for the exact estimation of enoxaparin sodium in injection formulation. This newly developed methodology is affordable in cost as long as less time is taken and the consumption of samples is in smaller quantities for every investigation. In medicinal chemistry, the USP (United States Pharmacopeia) and BP (British Pharmacopeia) are directly involved in production as well as in quality testing.

Association of red cell omega-3 fatty acids, particularly EPA, with cognitive performance in atrial fibrillation

Abstract Introduction Atrial fibrillation (AF) is associated with cognitive impairment and dementia. Whether or not omega-3 Fatty Acids (n-3 FAs) have neuroprotective effects is controversial. We therefore aimed to determine the correlation of n-3 FAs with cognitive function in a large cohort of AF patients. Methods Red cell n-3 FAs levels were determined by gas chromatography and mass spectrometry in 2359 patients from the prospective ongoing multicenter Swiss Atrial Fibrillation study (Swiss-AF). To assess the overall cognitive performance of patients, we used several validated neurocognitive assessment tools, including the Montreal Cognitive Assessment (MoCA), Semantic Fluency Tests (SF), Trail Making Test (TMT A&B), and the Digit Symbol Substitution Test (DST). We also used a summary score that we have previously developed (the cognitive construct (CoCo) score). We performed mixed-effect linear regression analyses. Two adjustment models were applied; model 1 (adjusted for age, sex, and educational level) and model 2 (adjusted for age, sex, educational level, history of stroke/TIA, AF type, heart rate, arterial hypertension, diabetes, coronary artery disease, BMI, chronic kidney disease, smoking status, alcohol consumption, geriatric depression scale, use of oral anticoagulation and antiplatelet medication). We also included a random intercept to control for center-effect in both models. Results The mean age of our study population was 73 years (standard deviation [SD] 8.4), and 662 patients were females (28%), 318 had a history of stroke (13%), and 716 suffered from coronary artery disease (30%). We observed statistically significant associations of total n-3 FAs levels (EPA + DHA + DPA + ALA) with all neurocognitive assessments, as seen in figure a. Individual n-3 FAs levels (EPA and ALA) were positively associated with MoCA score in both models. EPA was significantly associated with multiple neurocognitive assessments including MoCA, SF, TMT-B, DST, and overall CoCo score in both models (figure b). We found that a 1% red cell EPA level increase was associated with 0.19 (Model 1, 95%CI 0.06-0.31, p=0.003) and 0.14 (Model 2, 95% CI 0.01-0.26, p=0.02) units increase in the standardized MoCA score. Conclusions Red cell n-3 FAs levels are associated with better cognitive performance in AF patients. We observed a particularly strong association of EPA levels with all neurocognitive assessments.

Anticoagulatory treatment and clinical outcomes after transcatheter aortic valve implantation: results from 45,598 patients of the German Aortic Valve Registry (GARY)

Abstract Background Transcatheter aortic valve implantation (TAVI) has developed to the therapy of choice for patients with symptomatic severe aortic stenosis who are inoperable or at high or intermediate operative risk for surgical aortic valve replacement. However, the optimal anticoagulant therapy post-TAVI still remains a matter of debate and individual patient characteristics and comorbidities lead to the prescription of different regimens in clinical practice. Purpose This study investigates current anticoagulant treatment patterns and clinical outcomes in patients after TAVI in a real-world population. Methods The German Aortic Valve Registry (GARY) is a prospective, multicenter all-comers registry enrolling patients undergoing invasive treatment for aortic valve disease. From January 2011 to December 2019, 141,790 patients from 92 hospitals performing TAVI procedures in Germany were enrolled. Different anticoagulant treatment regimens were assessed at hospital discharge for patients after TAVI procedures. All-cause mortality and the combined endpoint "cardiac and cerebrovascular events" containing myocardial infarction (MI), stroke, transient ischaemic attack (TIA), aortic prosthesis re-intervention and all-cause mortality in the first year after TAVI were examined by treatment regimen. Results The study population comprised 45,598 patients with TAVI between 2011 and 2019: 46.5 % received dual antiplatelet therapy (DAPT), 25.7 % oral anticoagulation (OAC) plus antiplatelet therapy, 15.0 % single antiplatelet therapy (SAPT), 6.8 % OAC monotherapy, 4.7 % triple therapy and 1.3 % did not receive any anticoagulant medication. The majority of patients with oral anticoagulation were prescribed VKA (66.8 %) compared to DOAC (33.2 %). After adjustment for baseline confounders, cardiac and cerebrovascular event free survival did not differ significantly between patients with SAPT and DAPT (HR 0.94, 95% CI 0.89-1.00, p = 0.07), albeit the risk of all-cause mortality was slightly increased in SAPT (HR 1.24, 95% CI 1.12-1.37, p <0.001) and all regimens containing oral anticoagulation (OAC mono: HR 1.24, 95% CI 1.08-1.42, p = 0.002, OAC duo: HR 1.23, 95% CI 1.13-1.35, p < 0.001, OAC triple: HR 1.25, 95% CI 1.08-1.45, p = 0.003) compared to dual antiplatelet regime. In patients with OAC, the risk of all-cause mortality (HR 0.99, 95% CI 0.89-1.10, p = 0.81) and cardiac and cerebrovascular event free survival (HR 1.07, 95% CI 0.97-1.18, p = 0.17) was not significantly different in patients with DOAC-containing regimens when compared to VKA-containing regimens. Conclusions In an analysis from one of the world’s largest national registries of patients undergoing TAVI, we found comparative effectiveness of SAPT vs. DAPT and DOACs vs. VKA after TAVI with respect to cardiac and cerebrovascular events. The increased risk of all-cause mortality in patients with antiplatelet monotherapy might be confounded by unmeasured morbidity but requires further attention.Multivariate: Reference group DAPTMultivariate: Reference group VKA

Abstract 14284: Anticoagulant Effects of Edoxaban in Cancer and Non-Cancer Patients With Venous Thromboembolism

Introduction: Edoxaban, a direct oral anticoagulant (DOAC), is established as an anticoagulant medication in the treatment of venous thromboembolism (VTE) and suppression of VTE recurrences. While VTE recurrences in patients with cancer is greater than those in patients with non-cancer in spite of DOACs use, the reason is unclear. Anticoagulant effects of DOACs are not monitored because of less individual variability on their pharmacological effects and a short half-time. Although the plasma concentration of edoxaban correlates with prothrombin time (PT) and activated partial thromboplastin time (APTT) in healthy adults. PT and APTT are prolonged up to 5 hours after administration of edoxaban. Hypothesis: We hypothesized that anticoagulant effects of edoxaban are inhibited in patients with cancer and measured PT and APTT to assess its anticoagulant effects. Methods: This study is prospective observational study conducted in 12 hospitals. Patients with VTE taking edoxaban for treatment were included. PT and APTT were measured at 5-hours after first administration of edoxaban, and also measured at optional time after 7 days and/or 30 days. D-dimer, prothrombin fragment 1+2, and thrombin-antithrombin complex were measured once as coagulation markers. Results: Two hundred forty-three patients were included in the study, and 80 patients were with cancer. PT and APTT were measured at 465 points. PT and APTT at 5-hours after first administration of edoxaban were not significantly different between patients with cancer and non-cancer (17.1 ± 0.4 vs. 16.8 ± 0.3 seconds; PT, 35.1 ± 0.6 vs. 34.5 ± 0.5 seconds; APPT). PT values at 5-hours after first administration were prolonged compared with those at before administration in patients with cancer and non-cancer (13.8 ± 0.6 and 13.8 ± 0.4 seconds; before administration). Other coagulant markers were not significantly different between patients with cancer and non-cancer. Conclusions: Anticoagulant effects of edoxaban do not differ between patients with cancer and non-cancer, and those effects are sufficient. Greater VTE recurrences in patients with cancer may be due to hypercoagulable state by cancer, but not lowering anticoagulant effects of edoxaban.

Benefits and Harms of Standard Versus Reduced-Dose Direct Oral Anticoagulant Therapy for Older Adults With Multiple Morbidities and Atrial Fibrillation.

Background Dose reduction of direct oral anticoagulant (DOAC) medications is inconsistently applied to older adults with multiple morbidities, potentially due to perceived harms and unknown benefits of standard dosing. Methods and Results Using 2013 to 2017 US Medicare claims linked to Minimum Data Set records, we conducted a retrospective cohort study. We identified DOAC initiators (apixaban, dabigatran, rivaroxaban) aged ≥65 years with nonvalvular atrial fibrillation residing in a nursing home. We estimated inverse-probability of treatment weights for DOAC dose using propensity scores. We examined safety (hospitalization for major bleeding) and effectiveness outcomes (all-cause mortality, thrombosis [myocardial infarction, stroke, systemic embolism, venous thromboembolism]). We estimated hazard ratios (HRs) and 95% CIs using cause-specific hazard-regression models. Of 21 878 DOAC initiators, 48% received reduced dosing. The mean age of residents was 82.0 years, 66% were female, and 31% had moderate/severe cognitive impairment. After estimating inverse-probability of treatment weights, standard dosing was associated with a higher rate of bleeding (HR, 1.18 [95% CI, 1.03-1.37]; 9.4 versus 8.0 events per 100 person-years). Standard-dose therapy was associated with the highest rates of bleeding among those aged >80 years (9.1 versus 6.7 events per 100 person-years) and with a body mass index <30 kg/m2 (9.4 versus 7.4 events per 100 person-years). There was no association of dosing with mortality (HR, 0.99 [95% CI, 0.96-1.06]) or thrombotic events (HR, 1.16 [95% CI, 0.96-1.41]). Conclusions In this nationwide study of nursing home residents with nonvalvular atrial fibrillation, we found a higher rate of bleeding and little difference in effectiveness of standard versus reduced-dose DOAC treatment. Our results support the use of reduced-dose DOACs for many older adults with multiple morbidities.